Job Description
Regulatory Compliance & Governance
- Ensure compliance of healthcare, pharmaceutical, food, nutritional, veterinary, and medical device portfolios with SAHPRA, Act 36, and international regulations.
- Oversee product registrations, renewals, amendments, and dossier upgrades.
- Monitor, interpret, and implement changes in regulations, advising business and marketing teams.
- Approve and sign off product labelling, packaging, and marketing material in line with regulatory and advertising standards.
- Lead regulatory audits, compliance reviews, and risk assessments.
New Product Development (NPD) & Innovation
- Provide regulatory input during concept, development, and launch stages.
- Support formulation, actives sourcing, and compliance of new product pipelines.
- Draft and review product information leaflets, labels, and inserts.
- Project manage timelines for dossier submissions and new product launches.
Quality & Manufacturing Oversight
- Ensure adherence to GMP, PQMS, and site compliance requirements.
- Conduct gap analyses on dossiers and quality systems, implementing corrective actions.
- Develop validation protocols, product release protocols, and SOPs.
Exports & International Registrations
- Manage product registrations in SADC and other markets.
- Build and maintain relationships with international regulatory bodies.
Stakeholder Engagement & Risk Management
- Act as regulatory advisor to cross-functional teams.
- Maintain detailed regulatory project records and ensure clear audit trails.
- Identify, assess, and mitigate regulatory risks across business operations.
QUALIFICATIONS & EXPERIENCE
- Bachelor’s Degree in Pharmacy, Food Science, Nutrition, or related field.
- 5+ years’ experience in animal health regulatory affairs (healthcare and/or food).
- Strong knowledge of SAHPRA, Act 36, GMP & IAMA certification and international regulatory frameworks,
- Proven track record of managing product registrations, dossiers and NPD compliance.
- Experience liaising with regulatory authorities, managing audits, and driving compliance initiatives.
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